Dronabinol for Agitation in Dementia Crossover Trial

Behavioral Symptoms Clinical Trial

Official title: Single-site, Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Dronabinol for the Treatment of Agitation in Outpatient With Dementia

Status Not yet recruiting

Clinical Trial Summary

The goal of this clinical trial is to study the effects of dronabinol in US Veterans with agitation related to moderate to severe dementia. The main goals of the study are:

• To evaluate the efficacy of dronabinol for the treatment of agitation in moderate to severe dementia compared to placebo

• To evaluate the safety of dronabinol in the treatment of agitation in moderate to severe dementia compared to placebo

Fifty (50) subjects will be given either dronabinol or placebo for 8 weeks. All subjects will then undergo a "washout" phase for 3 weeks, followed by the crossover intervention (i.e. subjects who received placebo during the first phase will receive dronabinol during the second phase, and vice versa). Thus, all participants will be taking dronabinol at some point during the study. During the study, subjects will undergo evaluations for:

• Agitation

• Cognitive changes

• Physical changes (i.e. labs, ekg, physical exam)

Clinical Trial Description

The investigators will conduct a phase IIa study to evaluate the efficacy and safety of dronabinol in the treatment of agitation related to dementia in the US Veteran population.

Specific Aim 1 - To evaluate the efficacy of dronabinol (target dose 5 mg bid) for the treatment of agitation in dementia.

Hypothesis: Dronabinol improves clinically significant agitation in moderate to severe dementia. Approach: The investigators will conduct a 6-week, double-blind, placebo-controlled, crossover, exploratory study of 50 Veterans suffering from moderate to severe dementia and clinically significant agitation with the Cohen Mansfield Agitation Inventory (CMAI) total score as the main outcome measure. Impact: The potential benefit of dronabinol in agitation will be evaluated.

Specific Aim 2 - To evaluate the safety of dronabinol in the treatment of agitation in moderate to severe dementia.

Hypothesis: Dronabinol is safe for the treatment of agitation in moderate to severe dementia. Approach: Outcomes of safety monitoring are to be measured by physical examination, vital signs with weight, adverse event reports, electrocardiogram, safety labs including complete metabolic panel (CMP), complete blood count (CBC), urinalysis (UA), and treatment compliance. Impact: The potential adverse effects of the 5 mg dose of dronabinol will be evaluated.

Exploratory Aims - The investigators will also evaluate the effect of dronabinol on neuropsychiatric symptoms, caregiver distress, cognition, weight, nutritional status, pain, and inflammation. ;

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Alzheimer Disease
• Behavioral Symptoms
• Dementia
• Dementia Moderate
• Dementia Severe
• Psychomotor Agitation

• NCT number: NCT05612711
• Study type: Interventional
• Source: Ralph H. Johnson VA Medical Center
• Contact: Jacobo E Mintzer, MD
• Phone: 843-367-4260
• Email: jacobo.mintzer@va.gov
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2023
• Completion date: November 2026